BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15284200 · Received August 24, 2022

    Report

    Report Number
    2916596-2022-13179
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    August 19, 2022
    Report Date
    September 19, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE PUMP NOT ENGAGING TO THE MINI APICAL CUFF COULD NOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR EVALUATION AND NO IMAGES WERE SUBMITTED FOR ANALYSIS. ALTHOUGH A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE ACCOUNT INDICATED THAT THERE APPEARED TO BE HEART TISSUE PREVENTING THE PUMP FROM LOCKING TO THE MINI APICAL CUFF. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), WITH NO FURTHER ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) AS WELL AS THE MINI APICAL CUFF, LOT NUMBER 7900815, WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATION. THE HEARTMATE 3 MINI APICAL CUFF KIT INSTRUCTIONS FOR USE (IFU), REV. E, IS CURRENTLY AVAILABLE. THE SECTION ENTITLED ¿SURGICAL PROCEDURES¿ EXPLAINS HOW TO PREPARE THE MINI APICAL CUFF AND THE APICAL CUFF HOLDER FOR USE. THE SECTION ENTITLED ¿DIRECTIONS FOR USE¿ EXPLAINS HOW TO SECURE THE MINI APICAL CUFF TO THE VENTRICLE. THIS SECTION INSTRUCTS TO INSPECT THE ATTACHMENT AREA TO ENSURE THAT THE MINI APICAL CUFF AND SURROUNDING TISSUE PRODUCES NO INTERFERENCE THAT WOULD PREVENT THE DEVICE FROM APPROXIMATING THE MINI APICAL CUFF. THIS SECTION ALSO NOTES THAT THE MINI APICAL CUFF SHOULD BE AFFIXED ONLY BY THE SEW-THEN-CUT METHOD AND PLEDGETS SHOULD BE PLACED NO MORE THAN ONE AND A HALF CENTIMETERS FROM THE EDGE OF THE FELT. AFFIXING THE MINI APICAL CUFF USING METHODS OTHER THAN THE PRESCRIBED TECHNIQUE CAN LEAD TO CHALLENGES ENGAGING THE SLIDE LOCK MECHANISM. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) IFU, REV. C, IS ALSO CURRENTLY AVAILABLE. THE IFU PROVIDES INSTRUCTIONS ON ALL SURGICAL PROCEDURES, INCLUDING PREPARING THE VENTRICULAR APEX SITE AND INSERTING THE PUMP IN THE VENTRICLE. THE IFU CAUTIONS THAT AFTER THE APICAL CUFF HAS BEEN SEWN TO THE HEART, THE METAL RING ON THE APICAL CUFF SHOULD EXTEND ABOVE THE FELT SURFACE TO ALLOW PROPER ENGAGEMENT AND LOCKING WITH THE SLIDE LOCK OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD). NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON ATTACHED THE MINI CUFF TO THE VENTRICLE BUT WAS UNABLE TO ATTACH AND LOCK THE PUMP IN PLACE. THERE APPEARED TO BE HEART TISSUE THAT PREVENTED THE MINI CUFF FROM LOCKING INTO THE PUMP. THE MINI CUFF WAS REMOVED AND THE APICAL CUFF WAS ATTACHED. THE PUMP WAS ABLE TO BE ATTACHED AND LOCKED IN PLACE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: THERE WAS A SLIGHT DELAY IN PROCEDURE AND THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434257 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8437971 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male